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Effect of Extended-release Oxymorphone Taking With or Without Food on Cognitive Functioning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedVadis Research Corporation
ClinicalTrials.gov Identifier:
NCT00930943
First received: June 29, 2009
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.


Condition Intervention Phase
Chronic Pain
Drug: Oxymorphone ER (Opana ER)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Extended-release Oxymorphone Hydrochloride (Opana® ER), Taken Fasting Versus With Food, on Cognitive Functioning in Opioid-tolerant Subjects: a Randomized, Single-blinded, Cross-over Study

Resource links provided by NLM:


Further study details as provided by MedVadis Research Corporation:

Primary Outcome Measures:
  • Rapid Visual Information Processing Test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spatial Recognition Memory test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]
  • Spatial Working Memory Test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]
  • Verbal Recognition Memory Test [ Time Frame: 1 and 3 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxymorphone ER (Opana ER)
    40 mg qd twice
    Other Name: Opana ER
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Man or woman, 18-65 years of age, inclusive
  2. Able to provide informed consent and comply with all study procedures
  3. Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
  4. Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
  5. Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch
  6. Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing
  7. Weight at screening 100-300 pounds, inclusive

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
  3. Alcohol or substance abuse within 2 years of screening
  4. Consumption of alcohol within 24 hours of a screening or testing visit
  5. Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
  6. Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
  7. Epworth sleepiness scale (ESS) score 16 or higher at screening
  8. Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
  9. Any clinically significant illness that would interfere with study participation or put the subject at risk
  10. Exposure to investigational medication within 30 days of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930943

Locations
United States, Massachusetts
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481
Sponsors and Collaborators
MedVadis Research Corporation
Investigators
Principal Investigator: Egilius LH Spierings, MD, PhD MedVadis Research Corporation
  More Information

No publications provided

Responsible Party: MedVadis Research Corporation
ClinicalTrials.gov Identifier: NCT00930943     History of Changes
Other Study ID Numbers: 2009-133A
Study First Received: June 29, 2009
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by MedVadis Research Corporation:
opioid tolerant
chronic pain

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Oxymorphone
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014